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Getting Started
A
Guide for Investigators and Research Staff
What are the types of protocol review?
Convened IRB Review (Full Board)
Studies that involve more than minimal risk and/or involve particularly vulnerable populations (i.e., prisoners, individuals with diminished capacities) require Convened Review. These studies require a review of the proposed research at a convened meeting at which a quorum of IRB members is present. For the research to be approved, it must receive the approval of a majority of those members present .
Expedited IRB Review
Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. Expedited review is performed by the IRB chair, a designated voting member, or a group of voting members rather than by the entire convened IRB.
Exempt Review
When it is determined that the involvement of human subjects is in one of the six exempt categories listed in the Regulations [45 CFR 46.101(b)], it is exempt. The exempt categories include certain educational practices and tests, innocuous surveys of adults, study of existing data, public service programs and food evaluations. Any research study involving human subjects thought to be exempt must be submitted to the OPRS for an exemption determination. Exemption review is performed by senior OPRS staff and designated IRB members.
Determination of Whether an Activity Represents Human Subjects
When an activity is thought to not represent human subjects research, the form, Determination of Whether An Activity Represents Human Subjects Research, should be completed and submitted to the OPRS. The OPRS waives the requirement for submission of the human subjects determination form when the activity is limited to one or more of the categories below unless required for publication or by the sponsor:
- The project is limited to accessing one or more of the following public use datasets: Inter-University Consortium for Political and Social Research (ICPSR), U.S Bureau of the Census, National Center for Health Statistics, National Center for Educational Statistics, U.S. Bureau of Labor Statistics, National Election Studies, National Crime Victimization Survey: School Crime Supplement, 2003, National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), National Survey of America's Families (NSAF), and PRAMS.
- The project is limited to course-related activities designed specifically for educational or teaching purposes; where data is collected from and about human subjects as part of a class exercise or assignment and is not intended for use outside of the classroom.
- The activity is a case report involving the observation of a single patient whose novel condition or response to treatment was guided by the care provider’s judgment regarding the best interest of the individual.
- The project involves research that is limited to death records, autopsy materials, or cadaver specimens (provided that the cadaveric tissues/cells are not used for clinical investigations).
Any activity that is thought to not represent human subjects must be submitted to the OPRS for a determination. The determination whether an activity representing human subject research is performed by designated OPRS staff.
Minimal risk – The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
See Federal Policy for the Protection of Human Subjects (45 CFR 46.100(b) for a detailed description of exemption categories.
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